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Randomized phase II exploratory study of prophylactic amifostine in cancer patients who receive radical radiotherapy to the pelvis.

Katsanos KH, Briasoulis E, Tsekeris P, Batistatou A, Bai M, Tolis C, Capizzello A, Panelos I, Karavasilis V, Christodoulou D, Tsianos EV - J. Exp. Clin. Cancer Res. (2010)

Bottom Line: Of them, 6 patients belonged to the A group (6/21, 28.6%) and 12 to the R group (12/23, 52.2%).Amifostine side effects were mild.Amifostine treated patients were less likely to develop histologically detectable mucosal lesions, which indicate protection from acute mucosal injury.

View Article: PubMed Central - HTML - PubMed

Affiliation: 1st Department of Internal Medicine & Hepato-Gastroenterology Unit, Medical School of Ioannina, Leoforos Stavrou Niarxou, Ioannina, 451 10, Greece. etsianos@uoi.gr

ABSTRACT

Background: This study aimed to investigate the efficacy of prophylactic amifostine in reducing the risk of severe radiation colitis in cancer patients receiving radical radiotherapy to the pelvis.

Methods: Patients with pelvic tumours referred for radical radiotherapy who consented participation in this trial, were randomly assigned to receive daily amifostine (A) (subcutaneously, 500 mg flat dose) before radiotherapy or radiotherapy alone (R). Sigmoidoscopy and blinded biopsies were scheduled to conduct prior to initiation and following completion of radiotherapy and again 6 to 9 months later. Radiation colitis was assessed by clinical, endoscopic and histolopathological criteria.

Results: A total 44 patients were enrolled in this trial, the majority with rectal (20 patients) and cervical cancer (12 patients) and were assigned 23 in R arm and 21 in the A arm. In total 119 sigmoidoscopies were performed and 18 patients (18/44, 40.9%) were diagnosed with radiation colitis (15 grade 1 and 2, and 3 grade 3 and 4). Of them, 6 patients belonged to the A group (6/21, 28.6%) and 12 to the R group (12/23, 52.2%). Acute and grade IV radiation colitis was only developed in four patients (17.4%) in the R group. Amifostine side effects were mild. Amifostine treated patients were less likely to develop histologically detectable mucosal lesions, which indicate protection from acute mucosal injury.

Conclusions: Amifostine given subcutaneously can lower the risk of acute severe radiation colitis in patients who receive radical radiotherapy to pelvic tumors.

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A. Congested rectal mucosa with diffuse erythema in a case of grade I radiation colitis (RTOG/EORTC late radiation morbidity scale for large intestine). B. Ulcerated rectal mucosa with diffuse erythema, mucous and intermittent bleeding in a case of grade II radiation colitis (RTOG/EORTC late radiation morbidity scale for large intestine).
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Figure 1: A. Congested rectal mucosa with diffuse erythema in a case of grade I radiation colitis (RTOG/EORTC late radiation morbidity scale for large intestine). B. Ulcerated rectal mucosa with diffuse erythema, mucous and intermittent bleeding in a case of grade II radiation colitis (RTOG/EORTC late radiation morbidity scale for large intestine).

Mentions: Eighteen out of 44 patients (40.9%) were diagnosed with radiation colitis (RC). Of these 18 patients, 6 were in the A group (6/21 patients = 28.6%) and 12 in the R group (12/23 patients = 52.2%) [p = 0.29]. The endoscopic findings and grading of RC are listed in Table 2. Sigmoidoscopic findings ranged from minor signs of inflammation to more prominent signs of bowel mucosa injury (Figures 1A-B).


Randomized phase II exploratory study of prophylactic amifostine in cancer patients who receive radical radiotherapy to the pelvis.

Katsanos KH, Briasoulis E, Tsekeris P, Batistatou A, Bai M, Tolis C, Capizzello A, Panelos I, Karavasilis V, Christodoulou D, Tsianos EV - J. Exp. Clin. Cancer Res. (2010)

A. Congested rectal mucosa with diffuse erythema in a case of grade I radiation colitis (RTOG/EORTC late radiation morbidity scale for large intestine). B. Ulcerated rectal mucosa with diffuse erythema, mucous and intermittent bleeding in a case of grade II radiation colitis (RTOG/EORTC late radiation morbidity scale for large intestine).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2903531&req=5

Figure 1: A. Congested rectal mucosa with diffuse erythema in a case of grade I radiation colitis (RTOG/EORTC late radiation morbidity scale for large intestine). B. Ulcerated rectal mucosa with diffuse erythema, mucous and intermittent bleeding in a case of grade II radiation colitis (RTOG/EORTC late radiation morbidity scale for large intestine).
Mentions: Eighteen out of 44 patients (40.9%) were diagnosed with radiation colitis (RC). Of these 18 patients, 6 were in the A group (6/21 patients = 28.6%) and 12 in the R group (12/23 patients = 52.2%) [p = 0.29]. The endoscopic findings and grading of RC are listed in Table 2. Sigmoidoscopic findings ranged from minor signs of inflammation to more prominent signs of bowel mucosa injury (Figures 1A-B).

Bottom Line: Of them, 6 patients belonged to the A group (6/21, 28.6%) and 12 to the R group (12/23, 52.2%).Amifostine side effects were mild.Amifostine treated patients were less likely to develop histologically detectable mucosal lesions, which indicate protection from acute mucosal injury.

View Article: PubMed Central - HTML - PubMed

Affiliation: 1st Department of Internal Medicine & Hepato-Gastroenterology Unit, Medical School of Ioannina, Leoforos Stavrou Niarxou, Ioannina, 451 10, Greece. etsianos@uoi.gr

ABSTRACT

Background: This study aimed to investigate the efficacy of prophylactic amifostine in reducing the risk of severe radiation colitis in cancer patients receiving radical radiotherapy to the pelvis.

Methods: Patients with pelvic tumours referred for radical radiotherapy who consented participation in this trial, were randomly assigned to receive daily amifostine (A) (subcutaneously, 500 mg flat dose) before radiotherapy or radiotherapy alone (R). Sigmoidoscopy and blinded biopsies were scheduled to conduct prior to initiation and following completion of radiotherapy and again 6 to 9 months later. Radiation colitis was assessed by clinical, endoscopic and histolopathological criteria.

Results: A total 44 patients were enrolled in this trial, the majority with rectal (20 patients) and cervical cancer (12 patients) and were assigned 23 in R arm and 21 in the A arm. In total 119 sigmoidoscopies were performed and 18 patients (18/44, 40.9%) were diagnosed with radiation colitis (15 grade 1 and 2, and 3 grade 3 and 4). Of them, 6 patients belonged to the A group (6/21, 28.6%) and 12 to the R group (12/23, 52.2%). Acute and grade IV radiation colitis was only developed in four patients (17.4%) in the R group. Amifostine side effects were mild. Amifostine treated patients were less likely to develop histologically detectable mucosal lesions, which indicate protection from acute mucosal injury.

Conclusions: Amifostine given subcutaneously can lower the risk of acute severe radiation colitis in patients who receive radical radiotherapy to pelvic tumors.

Show MeSH
Related in: MedlinePlus